Drugs

FDA Says Inaccuracies in IQVIA Opioid Drug Data

FDA says agency scientists have discovered an inaccuracy in some data provided to the agency by a data vendor, IQVIA National Sales Perspectives, including data on certain opioid drug products. An agency statement says FDA found a discrepancy in the IQVIA data that showed a more than 20% drop in the reported amount, expressed in kilograms, of fentanyl sold for a minimum of the past five years compared to what the IQVIA database previously reported.

“Based on this investigation and discussions with IQVIA, it is our understanding that past data were overestimated by IQVIA because of an error in IQVIA’s methods, which we believe resulted from IQVIA utilizing the wrong weight-based conversion factors to determine the amount of fentanyl in a given unit (such as a single fentanyl patch) for a subset of prescription fentanyl products,” the statement says. “This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace when that estimated volume was expressed in kilograms.”

FDA says that as a result of looking into the IQVIA fentanyl data issues it has identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. “These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures,” FDA says.

IQVIA says it knew about the measurement conversion issue before it was notified by FDA and recently corrected the problem.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome